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Ganirelix: Uses, Evidence, and Reported Side Effects

Drafted by an automated content engine from FDA, PubChem, ClinicalTrials.gov, NIH DSLD, and Open Beauty Facts data.

Molecular formulaC80H113ClN18O13
Molecular weight1570.3 g/mol
Registered trials109
PubChem CID16130957
Brand namesGanirelix Acetate

Key takeaways

  • Ganirelix is approved to inhibit premature LH surges in women undergoing controlled ovarian hyperstimulation.
  • It is marketed as Ganirelix Acetate Injection and carries no boxed warning.
  • More than 100 registered trials have studied ganirelix, including completed Phase 4 work.
  • FAERS reports are dominated by ovarian hyperstimulation syndrome, a known risk in fertility treatment.
  • Reported cases must be read as counts of submitted reports, not confirmed rates of harm.

What ganirelix is

Ganirelix Acetate Injection is an approved fertility medication used during assisted reproduction cycles. It is given as part of controlled ovarian hyperstimulation protocols, where clinicians manage the timing of hormone surges to support egg development. The compound is identified in chemical databases under PubChem CID 16130957.

What ganirelix is approved for

Ganirelix Acetate Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation. This use targets a specific step in fertility treatment cycles rather than infertility broadly. No boxed warning is associated with this label.

What the evidence shows

Ganirelix has been studied in 109 registered clinical trials. A completed Phase 4 trial examined severe LH suppression patterns in patients after GnRH antagonist administration. Another Phase 4 study, still recruiting, is looking at how stress, sleep, and sex hormones relate to vascular aging in midlife women. A related Phase 3 trial comparing corifollitropin alfa to recombinant FSH in controlled ovarian stimulation was withdrawn.

Reported side effects

FAERS submissions for ganirelix are heavily weighted toward ovarian hyperstimulation syndrome, with 251 reports, reflecting a recognized risk of fertility stimulation regimens. Related fluid-related complications appear as well, including ascites (58 reports), dyspnoea (34), and pleural effusion (21). Gastrointestinal and general symptoms such as nausea (37), abdominal pain (28), and headache (26) were also reported, along with 26 reports describing the drug as ineffective. These figures represent counts of submitted reports, not confirmed incidence or proof that ganirelix caused the event.

FAQ

What is ganirelix used for?
Ganirelix is approved to inhibit premature LH surges in women undergoing controlled ovarian hyperstimulation. It is used as part of assisted reproduction cycles to help manage the timing of egg maturation. It is marketed under the brand name Ganirelix Acetate.
Does ganirelix have a boxed warning?
No. The approved label for Ganirelix Acetate Injection does not carry a boxed warning.
What are the most commonly reported side effects of ganirelix?
The most frequently reported issue in safety databases is ovarian hyperstimulation syndrome, with 251 reports. Other reported events include ascites, nausea, dyspnoea, and abdominal pain. These are counts of submitted reports rather than confirmed rates of occurrence.
How much clinical research exists on ganirelix?
Ganirelix has been examined in 109 registered clinical trials. Examples include a completed Phase 4 study on severe LH suppression and an ongoing Phase 4 trial on stress, sleep, and vascular aging in midlife women.
Is ovarian hyperstimulation syndrome common with ganirelix?
Ovarian hyperstimulation syndrome is the most frequently reported adverse event associated with ganirelix in safety databases, with 251 reports. This reflects reported cases, not a measured incidence rate, since FAERS data cannot establish causation or frequency in the treated population.
This page is an editorial information resource. It does not sell, prescribe, or recommend any medication. Content is editorial information, not medical advice. Talk to your doctor before any treatment decision.

Sources: DailyMed label FAERS adverse event reports ClinicalTrials.gov PubChem

Updated 2026-08-03